Effect of Vitamin D as Adjunctive Therapy in Patients With Pulmonary Evolution Tuberculosis (VitaminD)

National Institute of Respiratory Diseases (INER)

Status and phase: Unknown; Phase 4

Conditions: Pulmonary Tuberculosis

Treatments: Dietary Supplement: VitaminD

Study type: Interventional

Funder types: Other

Identifiers

NCT02464683

INERC50-13

Details and patient eligibility

About

Tuberculosis (TB) is the second largest infectious disease that causes death in the last 4 centuries in all the world. Observational studies found an association between vitaminD and TB, suggesting a potential therapeutic role of vitaminD supplementation in patients with active tuberculosis. The hypothesis is that the administration of vitaminD is associated with changes in the levels of cytokines in patients with tuberculosis treated with first-line drugs. The aim of this study is to evaluate the effect of vitaminD supplementation on the clinical course, the time of negative smears and cultures, and the effect on the immune response in patients with pulmonary tuberculosis (TBP).

Full description

We are going to include of 60 patients diagnosed with confirmed TBP with and without diabetes mellitus, by positive smear and culture for Mycobacterium tuberculosis sensitive to first-line drugs (rifampicin, isoniazid, pyrazinamide and ethambutol), which will be grouped as follows: 1) patients who receive vitamin D (VD) (n = 30) and 2) patients who not receive vitamin D (NVD) (n = 30) in addition to drug treatment of tuberculosis drug frontline. Blood samples must be taken each month until the end of treatment.The VD group of participants will receive treatment with a daily dose of Vitamin D 200 International Units (IU) during the first two months of treatment. All Patients who participate must give their written consent.

First, we are going to separate the peripheral blood mononuclear cells with Ficoll reagent. Then, for the determination of intracellular cytokines in basal conditions and after the antigenic stimulation with M.tuberculosis, the flow cytometric technique is going to be used and the results will be analyzing in a flow cytometer. We are going to infected cells with M. tuberculosis strain at a multiplicity of infection (MOI) of 1 and 10, in order to determinate phagocytosis and bactericidal activity of peripheral whole blood of patients, using Colony Forming Units (CFU) and staining. Extraction of RNA will be performed according to the kit supplier. The amplification reaction is going to perform with Applied Biosystems and Sybr Green Master Mix. We are going to use the unpaired Student t test, for the normal distribution parameters.

Enrollment: 60 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Men and women over 18 and under 65 years old, diagnosed with tuberculosis confirmed by positive smear and positive culture, without documented evidence of previous treatment for TB, with hemoglobin values greater than 10 g / dL, and written concent.

Exclusion criteria

• Patients diagnosed with HIV, or who do not give written concent, patients with chronic lung disease, patients with clinical evidence of infectious or chronic inflammatory disease processes such as; rheumatoid arthritis, patients with chronic lung disease, systemic lupus erythematosus (SLE), Sjögren Sx, dermatomyositis, scleroderma, seronegative arthritis, gout, inflammatory bowel disease, chronic active hepatitis, glomerulonephritis, rheumatic fever and patients with cardiac disease, cancer, and patients with a history of alcohol or drug abuse.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

60 participants in 2 patient groups, including a placebo group

Placebo

Placebo Comparator group

Description:

The patient will take a single tablet of placebo daily for 60 days. Each patient will go to the hospital in order to take the blood sample.

VitaminD

Experimental group

Description:

The patient will take a single tablet of Vitamin D (200 International Units) daily for 60 days. Each patient will go to the hospital in order to take the blood sample.

Treatment:

Dietary Supplement: VitaminD